Cleared Traditional

K081471 - ECARD AND CCARD

K081471 is the FDA 510(k) clearance for ECARD AND CCARD by iRhythm Technologies, Inc.. It is a Class 2 Cardiovascular device (product code DXH) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K081471 · iRhythm Technologies, Inc. · Cardiovascular device
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Jun 2008
Decision
28d
Days
Class 2
Risk

K081471 is an FDA 510(k) clearance for the ECARD AND CCARD. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by iRhythm Technologies, Inc. (San Francisco, US). The FDA issued a Cleared decision on June 24, 2008 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all iRhythm Technologies, Inc. devices

Submission Details

510(k) Number K081471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2008
Decision Date June 24, 2008
Days to Decision 28 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 93
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